DICLOFENAC SODIUM is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by H. J. Harkins Company Inc.. The primary component is Diclofenac Sodium.
| Product ID | 76519-1159_5fd9467f-9139-f7c9-e053-2a91aa0a5ef0 |
| NDC | 76519-1159 |
| Product Type | Human Prescription Drug |
| Proprietary Name | DICLOFENAC SODIUM |
| Generic Name | Diclofenac |
| Dosage Form | Gel |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2017-09-11 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA208077 |
| Labeler Name | H. J. Harkins Company Inc. |
| Substance Name | DICLOFENAC SODIUM |
| Active Ingredient Strength | 10 mg/1 |
| Pharm Classes | Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2017-09-11 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA208077 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-09-11 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| DICLOFENAC SODIUM | 10 mg/1 |
| SPL SET ID: | 5fd9467f-9138-f7c9-e053-2a91aa0a5ef0 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0115-1483 | Diclofenac Sodium | Diclofenac Sodium |
| 0168-0803 | DICLOFENAC SODIUM | diclofenac sodium |
| 0168-0844 | DICLOFENAC SODIUM | diclofenac sodium |
| 0228-2550 | Diclofenac Sodium | Diclofenac Sodium |
| 0228-2551 | Diclofenac Sodium | Diclofenac Sodium |
| 0363-1210 | Diclofenac sodium | Diclofenac sodium |
| 0363-1871 | diclofenac sodium | diclofenac sodium |
| 0378-0355 | Diclofenac Sodium | Diclofenac Sodium |
| 0378-6280 | Diclofenac Sodium | diclofenac sodium |
| 0378-6281 | Diclofenac Sodium | diclofenac sodium |
| 67544-899 | Diclofenac Sodium | Diclofenac Sodium |
| 68001-200 | Diclofenac Sodium | Diclofenac Sodium |
| 68001-201 | Diclofenac Sodium | Diclofenac Sodium |
| 68001-202 | Diclofenac Sodium | Diclofenac Sodium |
| 68001-279 | Diclofenac Sodium | Diclofenac Sodium |
| 68001-280 | Diclofenac Sodium | Diclofenac Sodium |
| 68001-281 | Diclofenac Sodium | Diclofenac Sodium |
| 68071-2045 | Diclofenac Sodium | Diclofenac Sodium |
| 68071-3159 | Diclofenac sodium | Diclofenac sodium |
| 68071-3325 | Diclofenac Sodium | Diclofenac Sodium |
| 68071-3132 | Diclofenac Sodium | Diclofenac Sodium |
| 68071-4158 | Diclofenac Sodium | Diclofenac Sodium |
| 68071-4382 | Diclofenac Sodium | Diclofenac Sodium |
| 68071-4246 | Diclofenac sodium | Diclofenac sodium |
| 68084-333 | Diclofenac Sodium | Diclofenac Sodium |
| 68151-0849 | Diclofenac Sodium | Diclofenac Sodium |
| 68151-2481 | Diclofenac Sodium | Diclofenac Sodium |
| 68180-538 | Diclofenac Sodium | Diclofenac Sodium |
| 0472-1783 | Diclofenac Sodium | Diclofenac Sodium |
| 68387-260 | Diclofenac Sodium | Diclofenac Sodium |
| 68382-999 | Diclofenac sodium | Diclofenac sodium |
| 68462-355 | DICLOFENAC SODIUM | DICLOFENAC SODIUM |
| 68682-103 | Diclofenac Sodium | Diclofenac Sodium |
| 68788-7270 | Diclofenac Sodium | Diclofenac Sodium |
| 68788-6368 | Diclofenac Sodium | Diclofenac Sodium |
| 68788-6388 | Diclofenac Sodium | Diclofenac Sodium |
| 68788-6831 | Diclofenac sodium | Diclofenac sodium |
| 68788-7225 | Diclofenac sodium | Diclofenac sodium |
| 68788-7097 | Diclofenac Sodium | Diclofenac Sodium |
| 68788-6952 | Diclofenac Sodium | Diclofenac Sodium |
| 68788-9231 | Diclofenac Sodium | Diclofenac Sodium |
| 68788-9389 | Diclofenac Sodium | Diclofenac Sodium |
| 68788-9523 | Diclofenac Sodium | Diclofenac Sodium |
| 68788-9175 | Diclofenac Sodium | Diclofenac Sodium |
| 68788-9185 | Diclofenac Sodium | Diclofenac Sodium |
| 68788-9435 | DICLOFENAC SODIUM | DICLOFENAC SODIUM |
| 69097-524 | Diclofenac Sodium | Diclofenac Sodium |
| 0527-2170 | Diclofenac Sodium | Diclofenac Sodium |
| 69621-300 | Diclofenac Sodium | Diclofenac Sodium |
| 69837-399 | DICLOFENAC SODIUM | DICLOFENAC SODIUM |